Recombinant DNA Advisory Committee - 5/30-31/91 
residual tumor. He noted that Dr. Brenner did not address this issue in his letter that was 
sent as a follow-up to the HGTS meeting. He said he would defer to Dr. Walters whether 
the response to this was adequate. 
Dr. Atlas said that with regard to the second provision laid down by the HGTS in regard to 
the stopping rule that he felt there was some confusion as to which document actually was the 
one supplied in response to this request. He said his comments would be based on tab 1435. 
He said he was concerned about the first paragraph which indicates that there is now another 
procedure under development that may obviate the gene marking and that this would cause 
the study to be stopped. He said it wasn't clear to him what percent of patients would be 
treated with this new procedure and whether it was sensitive enough to determine that the 
gene marking protocol was not necessary. 
Dr. Atlas said there were also problems with the informed consent document. First, he said 
he was not convinced that the form would be intelligible to a child of 7 years of age. Further, 
he wanted to know how some of the information would be used, in particular studies which 
are to be done before treatment. He said it was unclear whether these results would be used 
as entrance criteria and further whether the patient would be notified of the findings resulting 
from these studies. Further, he noted there were typographical errors in the document. 
Dr. Atlas commented that he felt this consent form had the same problem as many others that 
had been reviewed to date in that it failed to separate the separate the alternate procedures 
that are potentially therapeutic from the gene marking procedure which has a negligible 
chance of providing any therapeutic value to the patients. He said there was a need to 
separate these issues of therapy from issues of research. Finally, in the consent form, he 
noted that paragraph 8 was the only time the phrase "my child's care" is missing in 
descriptions of what is to be undertaken and he said he assumed this was a typographical 
error and said he believed it should be corrected to the standardized form of "my (my child's) 
care." 
Mr. Brewer said his concerns were mainly with the consent form and that Dr. Atlas had 
covered most of them. He said there was a general question of formatting which he believed 
needed to be discussed. He suggested that the logical flow of the document was not very good 
and suggested the investigators use the examples from Pittsburgh and M.D. Anderson as 
models to follow, provided their local institutional committees had no problems with this. 
Secondly, Mr. Brewer said that clearly there are different risks involved in the therapeutic 
portions of the study than there are in the gene marking portions and he said he felt these 
should be kept separate for clarity. He also suggested adding a sentence, as in Dr. 
Deisseroth's protocol, relative to the fact that a negative result may not result in any useful 
information being gained. He said that in consent forms which had been reviewed in the past 
there was a statement which recognized that no monetary payment would be made in the 
event of physical injury or illness while on the protocol which required amending to state that 
this was only the case for non-negligent injury or illness. He said this should be corrected to 
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